| Primary Device ID | 00817089020115 | 
| NIH Device Record Key | 36f22a44-aef9-4d93-966e-4e06e3595dbf | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Diazyme | 
| Version Model Number | DZ133C-CON | 
| Company DUNS | 080507219 | 
| Company Name | DIAZYME LABORATORIES, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | true | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00817089020115 [Primary] | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-11-03 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  DIAZYME  76016954  2586200 Live/Registered | General Atomics, Inc. 2000-04-03 | 
|  DIAZYME  74344385  1800360 Live/Registered | DANISCO US INC. 1992-12-30 | 
|  DIAZYME  71147806  0172650 Live/Registered | Takamine Laboratory, Inc. 1921-05-16 |